NCT05710471

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV, and plans to specifically target those who are not responding to standard Treat and Extend (T\&E) treatment. A randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the T\&E protocol

Detailed description

In addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. The primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. In addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Brolucizumab	Intravitreal injection
DRUG	Aflibercept	Intravitreal injection

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-07-25
• Completion: 2023-08-30
• First posted: 2023-02-02
• Last updated: 2024-05-08

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study